FDA seeks feedback BLA procedures and requirements, collection of information related to CGMP and transfusion-transmitted infections

Feb. 24, 2023
Regulatory update.

The Food and Drug Administration announced two opportunities for public comment relevant to the blood and biotherapies community.

First, the agency is seeking feedback from licensed manufacturers of biological products on regulations and recommendations related to biologics license applications (BLA) procedures and requirements. BLAs are regulated under parts 600 through 680 of Title 21 of the Code of Federal Regulations (21 CFR parts 600 through 680). Collection instruments related to these provisions include several forms, cover sheets and guidance documents.

FDA estimates 371 total annual responses and an overall burden for the information collection of 907,806 hours. This includes an increase of 467,907 hours, which reflects an increase in the number of annual submissions the agency has received over the past few years. The comment period closes on March 23.

Additionally, the agency is soliciting comments from establishments that collect blood and blood components for transfusion or further manufacture on an information collection request related to current good manufacturing practice (CGMP) for blood and blood components. The proposed information collection includes a revised information collection recommendation to account for the reporting burden found in guidance related to reducing the risk of transfusion-transmitted infection.

As stated in the Federal Register notice, several guidance documents provide recommendations for consignee and physician notification in circumstances where a blood establishment may receive information following collection that reveals the donor had a risk factor for a relevant TTI at the time of collection and should have been deferred for the risk factor. While the FDA believes these notifications are rare and likely addressed by existing standard operating procedures, the agency estimates one response and 1 hour annually for burden of the proposed collection of information.

Interested individuals may submit written or electronic feedback by April 23.

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